WO2011130834A8 - Forme dosifiée non intraveineuse comprenant une formulation solide d'un agent liquide biologiquement actif et ses utilisations - Google Patents

Forme dosifiée non intraveineuse comprenant une formulation solide d'un agent liquide biologiquement actif et ses utilisations Download PDF

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Publication number
WO2011130834A8
WO2011130834A8 PCT/CA2011/000447 CA2011000447W WO2011130834A8 WO 2011130834 A8 WO2011130834 A8 WO 2011130834A8 CA 2011000447 W CA2011000447 W CA 2011000447W WO 2011130834 A8 WO2011130834 A8 WO 2011130834A8
Authority
WO
WIPO (PCT)
Prior art keywords
active agent
dosage form
biologically active
liquid biologically
intravenous dosage
Prior art date
Application number
PCT/CA2011/000447
Other languages
English (en)
Other versions
WO2011130834A1 (fr
Inventor
Francois Ravenelle
Dorothee Le Garrec
David Lessard
Sandra Gori
Damon Smith
Miloud Rahmouni
Vinayak Sant
Original Assignee
Labopharm Inc.
Labopharm (Barbados) Limited
Labopharm Europe Limited
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Labopharm Inc., Labopharm (Barbados) Limited, Labopharm Europe Limited filed Critical Labopharm Inc.
Priority to JP2013505286A priority Critical patent/JP2013530931A/ja
Priority to EP11771439.4A priority patent/EP2563349A4/fr
Priority to CA2797098A priority patent/CA2797098C/fr
Priority to US13/643,038 priority patent/US20130039864A1/en
Publication of WO2011130834A1 publication Critical patent/WO2011130834A1/fr
Priority to IL222568A priority patent/IL222568A/en
Publication of WO2011130834A8 publication Critical patent/WO2011130834A8/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K31/00—Medicinal preparations containing organic active ingredients
    • A61K31/045—Hydroxy compounds, e.g. alcohols; Salts thereof, e.g. alcoholates
    • A61K31/05—Phenols
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/0012—Galenical forms characterised by the site of application
    • A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
    • A61K9/0056—Mouth soluble or dispersible forms; Suckable, eatable, chewable coherent forms; Forms rapidly disintegrating in the mouth; Lozenges; Lollipops; Bite capsules; Baked products; Baits or other oral forms for animals
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/10—Dispersions; Emulsions
    • A61K9/107—Emulsions ; Emulsion preconcentrates; Micelles
    • A61K9/1075—Microemulsions or submicron emulsions; Preconcentrates or solids thereof; Micelles, e.g. made of phospholipids or block copolymers
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/16—Agglomerates; Granulates; Microbeadlets ; Microspheres; Pellets; Solid products obtained by spray drying, spray freeze drying, spray congealing,(multiple) emulsion solvent evaporation or extraction
    • A61K9/1605—Excipients; Inactive ingredients
    • A61K9/1629—Organic macromolecular compounds
    • A61K9/1635—Organic macromolecular compounds obtained by reactions only involving carbon-to-carbon unsaturated bonds, e.g. polyvinyl pyrrolidone, poly(meth)acrylates
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
    • A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
    • A61K9/00—Medicinal preparations characterised by special physical form
    • A61K9/20—Pills, tablets, discs, rods
    • A61K9/2095—Tabletting processes; Dosage units made by direct compression of powders or specially processed granules, by eliminating solvents, by melt-extrusion, by injection molding, by 3D printing
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P1/00—Drugs for disorders of the alimentary tract or the digestive system
    • A61P1/08—Drugs for disorders of the alimentary tract or the digestive system for nausea, cinetosis or vertigo; Antiemetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P23/00—Anaesthetics
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/02—Drugs for disorders of the nervous system for peripheral neuropathies
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/04—Centrally acting analgesics, e.g. opioids
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/06—Antimigraine agents
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
    • A61P25/00—Drugs for disorders of the nervous system
    • A61P25/20—Hypnotics; Sedatives

Landscapes

  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Veterinary Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Pharmacology & Pharmacy (AREA)
  • Public Health (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Medicinal Chemistry (AREA)
  • Epidemiology (AREA)
  • Engineering & Computer Science (AREA)
  • Bioinformatics & Cheminformatics (AREA)
  • Chemical Kinetics & Catalysis (AREA)
  • Organic Chemistry (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • General Chemical & Material Sciences (AREA)
  • Neurosurgery (AREA)
  • Neurology (AREA)
  • Biomedical Technology (AREA)
  • Biophysics (AREA)
  • Zoology (AREA)
  • Physiology (AREA)
  • Pain & Pain Management (AREA)
  • Anesthesiology (AREA)
  • Molecular Biology (AREA)
  • Dispersion Chemistry (AREA)
  • Nutrition Science (AREA)
  • Hospice & Palliative Care (AREA)
  • Otolaryngology (AREA)
  • Medicinal Preparation (AREA)
  • Acyclic And Carbocyclic Compounds In Medicinal Compositions (AREA)
  • Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
  • Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)

Abstract

L'invention concerne une forme dosifiée non intraveineuse pour l'administration d'un agent liquide biologiquement actif. La forme dosifiée contient une formulation solide de l'agent liquide biologiquement actif, par exemple propofol, en association étroite avec au moins un agent stabilisateur, par exemple un polymère ou un tensio-actif amphiphile. Un agent liquide biologiquement actif est converti en un produit solide, par exemple une poudre, qui peut être facilement incorporé dans de nombreuses formes dosifiées non intraveineuses différentes. Après hydratation, une nanodispersion ou une micelle chargée de l'agent actif est formée. La forme dosifiée peut apporter une voie d'administration non intraveineuse pour des agents actifs qui sont typiquement seulement administrés par voie intraveineuse. L'invention concerne également des procédés, des utilisations, des trousses et des présentations commerciales liés à la forme dosifiée non intraveineuse.
PCT/CA2011/000447 2010-04-23 2011-04-21 Forme dosifiée non intraveineuse comprenant une formulation solide d'un agent liquide biologiquement actif et ses utilisations WO2011130834A1 (fr)

Priority Applications (5)

Application Number Priority Date Filing Date Title
JP2013505286A JP2013530931A (ja) 2010-04-23 2011-04-21 液状生物学的活性成分の固形製剤を含む非静脈内剤型およびその使用
EP11771439.4A EP2563349A4 (fr) 2010-04-23 2011-04-21 Forme dosifiée non intraveineuse comprenant une formulation solide d'un agent liquide biologiquement actif et ses utilisations
CA2797098A CA2797098C (fr) 2010-04-23 2011-04-21 Forme dosifiee non intraveineuse comprenant une formulation solide d'un agent liquide biologiquement actif et ses utilisations
US13/643,038 US20130039864A1 (en) 2010-04-23 2011-04-21 Non-Intravenous Dosage Form Comprising Solid Formulation of Liquid Biologically Active Agent and Uses Thereof
IL222568A IL222568A (en) 2010-04-23 2012-10-21 A dosage form not intended for intravenous administration containing a solid composition of a biologically active liquid agent and its uses

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US32734810P 2010-04-23 2010-04-23
US61/327,348 2010-04-23

Publications (2)

Publication Number Publication Date
WO2011130834A1 WO2011130834A1 (fr) 2011-10-27
WO2011130834A8 true WO2011130834A8 (fr) 2013-01-10

Family

ID=44833585

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/CA2011/000447 WO2011130834A1 (fr) 2010-04-23 2011-04-21 Forme dosifiée non intraveineuse comprenant une formulation solide d'un agent liquide biologiquement actif et ses utilisations

Country Status (6)

Country Link
US (1) US20130039864A1 (fr)
EP (1) EP2563349A4 (fr)
JP (2) JP2013530931A (fr)
CA (1) CA2797098C (fr)
IL (1) IL222568A (fr)
WO (1) WO2011130834A1 (fr)

Families Citing this family (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20060198891A1 (en) 2004-11-29 2006-09-07 Francois Ravenelle Solid formulations of liquid biologically active agents
US20130039864A1 (en) * 2010-04-23 2013-02-14 Francois Ravenelle Non-Intravenous Dosage Form Comprising Solid Formulation of Liquid Biologically Active Agent and Uses Thereof
WO2017205632A1 (fr) * 2016-05-27 2017-11-30 The Johns Hopkins University Administration buccale, sublinguale et intranasale de fospropofol
JP6912876B2 (ja) * 2016-10-06 2021-08-04 三洋化成工業株式会社 アクリル系医薬固形製剤用添加剤
GB2561009B (en) 2017-03-31 2020-05-13 Altus Formulation Inc Non-ionic PVP-PLA block copolymers and pharmaceutical compositions derived therefrom

Family Cites Families (13)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1120109A3 (fr) * 2000-01-24 2002-07-10 Pfizer Products Inc. Formes posologiques solides à désintégration et dissolution rapide
US6338859B1 (en) * 2000-06-29 2002-01-15 Labopharm Inc. Polymeric micelle compositions
US6623765B1 (en) * 2000-08-01 2003-09-23 University Of Florida, Research Foundation, Incorporated Microemulsion and micelle systems for solubilizing drugs
US6780324B2 (en) * 2002-03-18 2004-08-24 Labopharm, Inc. Preparation of sterile stabilized nanodispersions
PT1558935E (pt) * 2002-10-25 2008-10-16 Labopharm Inc Composições de libertação controlada
WO2005009357A2 (fr) * 2003-07-23 2005-02-03 Pr Pharmaceuticals, Inc. Compositions a liberation controlee
JP2007524661A (ja) * 2003-12-17 2007-08-30 エムジーアイ ジーピー インコーポレイティッド 長期鎮静のためのプロポフォールの水溶性プロドラッグの投与の方法
US20060198891A1 (en) * 2004-11-29 2006-09-07 Francois Ravenelle Solid formulations of liquid biologically active agents
JP2010504318A (ja) * 2006-09-22 2010-02-12 ラボファーム インコーポレイテッド ｐＨ標的化薬剤送達のための組成物及び方法
US20110038939A1 (en) * 2007-07-16 2011-02-17 Northeastern University Therapeutic stable nanoparticles
AU2008303129B2 (en) * 2007-09-25 2013-08-01 Formulex Pharma Innovations Ltd. Compositions comprising lipophilic active compounds and method for their preparation
FR2930444B1 (fr) * 2008-04-29 2010-06-04 Servier Lab Micelles polymerisees
US20130039864A1 (en) * 2010-04-23 2013-02-14 Francois Ravenelle Non-Intravenous Dosage Form Comprising Solid Formulation of Liquid Biologically Active Agent and Uses Thereof

Also Published As

Publication number Publication date
CA2797098C (fr) 2019-03-26
JP6572256B2 (ja) 2019-09-04
US20130039864A1 (en) 2013-02-14
CA2797098A1 (fr) 2011-10-27
EP2563349A4 (fr) 2014-03-19
WO2011130834A1 (fr) 2011-10-27
JP2017186346A (ja) 2017-10-12
JP2013530931A (ja) 2013-08-01
IL222568A0 (en) 2012-12-31
IL222568A (en) 2017-05-29
EP2563349A1 (fr) 2013-03-06

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